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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Operating, Dental
510(k) Number K912142
Device Name MICRONAIRE ISO-HOOD MAX 5UV
Applicant
Micronaire Corp.
705 Laurens Rd.
Greenville,  SC  29607
Applicant Contact NATHANIAL E.CAIN
Correspondent
Micronaire Corp.
705 Laurens Rd.
Greenville,  SC  29607
Correspondent Contact NATHANIAL E.CAIN
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received05/14/1991
Decision Date 10/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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